CLASS I Device recall · Reported 22 Aug 2012 · FDA Enforcement Report
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System recalled
Stryker Instruments Div. of Stryker is recalling Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System, distributed nationwide in the US. The recall was initiated on 8 Jun 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2062-2012
- FDA event ID
- 61747
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Jun 2012
- FDA classified
- 14 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 Jun 2012 | Recall initiated by company | |
| 14 Aug 2012 | Classified by FDA | +67 days |
| 22 Aug 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Warning Labels, which are pending distribution, are required on all Neptune devices. Further investigation found the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. FDA advises Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.
Product as listed by the FDA
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Where it was distributed
Worldwide Distribution -- USA (nationwide) and country of: Canada. .
Questions about this recall
Why was it recalled?
Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Warning Labels, which are pending distribution, are required on all Neptune devices. Further investigation found the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. FDA advises Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.
Which lots are affected?
120V Gold part numbers 0700-001-000 IFU 0700-001-700 230 V Gold 0700-002- 000, IFU 0700-002-707 Neptune 1 Gold Rover 0700-001-000 1/11/01 12/23/09 3/26/01 1/30/10 0700-001-700 Neptune 1 Gold Rover - International 0700-002-000 9/15/05 10/3/05 10/3/05 0700-002-707
Where was it sold?
Worldwide Distribution -- USA (nationwide) and country of: Canada. .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 61747This product is part of a recall event; the main page for the event is Neptune 1 Silver Rover, Part 0700-003-000 Stryker recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Neptune 1 Silver Rover, Part 0700-003-000 Stryker recalled | Stryker Instruments Div. of Stryker | Other | Nationwide | |
| CLASS I | Neptune Rover Waste Management System recalled | Stryker Instruments Div. of Stryker | Other | Nationwide | |
| CLASS I | Stryker Neptune Bronze Rover recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Other | Nationwide |
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